AgingPhase 3NCT03529929
Glucocorticoid Inflammation Paradox in Human Skeletal Muscle
A Phase 3 study testing Methylprednisolone in people with Aging, run by Texas A&M University at 1 site in United States.
Trial summary
In this project, we propose to investigate the metabolic consequences of glucocorticoid therapy, given orally as a 6 day Medrol Dose pack, on human skeletal muscle as measured by western blotting and PCR and skeletal muscle mitochondrial capacity as measured by High-Resolution Respirometry in healthy individuals. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Methylprednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 1 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages: 60 - 80 years.
- For men only: Eugonadal men, with a basal serum testosterone level for men within the normal range for the assay.
- For women only: women must be post-menopausal.
- Availability of transportation (i.e., subjects must be able to provide their own transportation to TAMU HCRF).
- Ability to fast for 12 hours before each of the study visits
Who cannot join
- Use of anticoagulant due to the risk of bleeding during the muscle biopsy procedure.
- Current use or history of recent use of anabolic steroids or glucocorticoids (within 3 months).
- Use of anti-bone-resorptive agents such as bisphosphonates, parathyroid hormone, or calcitonin.
- Use of live virus vaccines in the past 30 days.
- History of stroke.
- History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months.
Show all 21Show fewer
- Diagnosed systemic viral, bacterial, or fungal infections.
- Any established major medical illness such as chronic obstructive pulmonary disease, or untreated sleep apnea.
- Subjects with minor, acute inflammatory illnesses such as colds will be excluded until the acute illness has resolved.
- Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes).
- History or current diagnosis of type 1 or type 2 diabetes. High doses of glucocorticoids can increase insulin resistance and exacerbate diabetes.
- Systolic blood pressure greater than or equal to 160mm Hg or a diastolic blood pressure greater than or equal to 100mm Hg on three consecutive measurements taken at one-week intervals. Glucocorticoids can cause fluid retention that could worsen uncontrolled hypertension. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria.
- Subjects who engage in high intensity, elite training on a regular basis will be excluded. Additionally, subjects will be asked to refrain from any exercise during study week.
- History of seizure disorder.
- History of tuberculosis.
- Current diagnosis of peptic ulcer disease, gastritis, or non-ulcer dyspepsia.
- Current diagnosis of mental illness.
- Current diagnosis of cognitive impairment.
- Subjects with sleep disturbances.
- Current self-reported immunosuppressive disorder.
- Any other condition or event considered exclusionary by the PI and covering physician.
Trial locations and contacts
1 site in 1 country.
About this study
In this project, we propose to investigate the metabolic consequences of glucocorticoid therapy, given orally as a 6 day Medrol Dose pack, on human skeletal muscle as measured by western blotting and PCR and skeletal muscle mitochondrial capacity as measured by High-Resolution Respirometry in healthy individuals. Medrol is an FDA approved drug with many clinical indications.
Read the detailed description
Healthy male and female individuals ages 60 - 80 (n=10) will be studied before and after 6 days of treatment with self-administered daily oral methylprednisolone.
Subjects will report to the Texas A\&M Human Clinical Research Facility (HCRF) for testing before (day 0) and after (day 6) methylprednisolone intervention. Each visit will consist of determination of lean and fat mass using DEXA and a single muscle biopsy. Blood will be collected (up to 15ml) at screening, baseline and the conclusion of the study to measure metabolites and hormones. Phone calls will be made to subjects mid-week (day 3) during the study period to ensure compliance and continued consent.
This will be an unblinded study. All participants will receive methylprednisolone treatment.
Therapeutic Interventions. Methylprednisolone (Medrol®) dose pack. Methylprednisolone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Therapeutic methylprednisolone is approved for clinical use for a variety of disorders. Medrol®, the agent to be used in this study, is manufactured by Pfizer.
Medrol® is supplied as white tablets, of 4mg each. The tablets come in a commercially produced blister pack with instructions for each day of the 6 day dosing on the packaging. Subjects will receive a standard 6-day, graded dosing regimen of methylprednisolone (24mg, 20mg, 16mg, 12mg, 8mg, and 4 mg on days 1 through 6 respectively, Table 1 above). This methylprednisolone dosing regimen is commonly prescribed for the treatment of inflammation associated with a number of pathologies, including arthritic, respiratory, and neoplastic diseases. The Medrol® pack has clear instructions on how to administer the tablets and participants will be given additional instruction to ensure understanding for proper self-administration.
- Conditions
- Aging
- Being tested
- Methylprednisolone
- Keywords
- glucocorticoids, aging, NFKB, Medrol, methylprednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Medrol Dose Pack, Medrol
6 day dosing as dictated by Medrol 6 Day Dose Pack
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Experimental | Methylprednisolone glucocorticoid Medrol Dose Pack
Medrol is supplied as white tablets, of 4mg each. The tablets come in a commercially produced blister pack with instructions for each day of the 6 day dosing on the packaging. Subjects will receive a standard 6-day, graded dosing regimen of methylprednisolone (24mg, 20mg, 16mg, 12mg, 8mg, and 4 mg on days 1 through 6 respectively). Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative Phosphorylation Capacity measured by high resolution tissue respirometry on day 0
Oxidative Phosphorylation will be measured in muscle tissue using high resolution respirometry (Oroboros O2K) on day 0.
Measured: day 0
Oxidative Phosphorylation Capacity measured by high resolution tissue respirometry on day 6
Oxidative Phosphorylation will be measured in muscle tissue using high resolution respirometry (Oroboros O2K) on day 6, after the 6 day methylpredinsolone treatment.
Measured: day 6
Expression level of NFKB Inducing Kinase (NIK) in tissue measured by real time PCR on day 0
NIK expression will be measured in muscle tissue using real time PCR on day 0.
Measured: day 0
Expression level of NFKB Inducing Kinase (NIK) in tissue measured by real time PCR on day 6
NIK expression will be measured in muscle tissue using real time PCR on day 6, after the 6 day methylprednisolone treatment.
Measured: day 6
Secondary outcomes (4)
Lean Body Mass as measured by Dual Energy X-Ray Absorptiometry on day 0
Lean body mass will be measured using a Hologic DEXA on day 0.
Measured: day 0
Lean Body Mass as measured by Dual Energy X-Ray Absorptiometry on day 6
Lean body mass will be measured using a Hologic DEXA on day 6, after the 6 day methylprednisolone treatment.
Measured: day 6
Fat Mass as measured by Dual Energy X-Ray Absorptiometry on day 0
Fat mass will be measured using a Hologic DEXA on day 0.
Measured: day 0
Fat Mass as measured by Dual Energy X-Ray Absorptiometry on day 6
Fat mass will be measured using a Hologic DEXA on day 6, after the 6 day methylprednisolone treatment.
Measured: day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 Jun 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Why it stopped: withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melinda Sheffield-Moore, Texas A&M University
- Investigators
- Melinda Sheffield-Moore, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529929
- Sponsor's protocol ID
- IRB2017-0883
- Status last verified
- Mar 2020
- First submitted
- 20 Apr 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticoid Inflammation Paradox in Human Skeletal Muscle
- ClinicalTrials.gov ID
- NCT03529929
- Acronym / sponsor ID
- IRB2017-0883
- Conditions
- Aging
- Keywords
- glucocorticoids, aging, NFKB, Medrol, methylprednisolone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this project, we propose to investigate the metabolic consequences of glucocorticoid therapy, given orally as a 6 day Medrol Dose pack, on human skeletal muscle as measured by western blotting and PCR and skeletal muscle mitochondrial capacity as measured by High-Resolution Respirometry in healthy individuals. Medrol is an FDA approved drug with many clinical indications.
Detailed description
Healthy male and female individuals ages 60 - 80 (n=10) will be studied before and after 6 days of treatment with self-administered daily oral methylprednisolone.
Subjects will report to the Texas A\&M Human Clinical Research Facility (HCRF) for testing before (day 0) and after (day 6) methylprednisolone intervention. Each visit will consist of determination of lean and fat mass using DEXA and a single muscle biopsy. Blood will be collected (up to 15ml) at screening, baseline and the conclusion of the study to measure metabolites and hormones. Phone calls will be made to subjects mid-week (day 3) during the study period to ensure compliance and continued consent.
This will be an unblinded study. All participants will receive methylprednisolone treatment.
Therapeutic Interventions. Methylprednisolone (Medrol®) dose pack. Methylprednisolone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Therapeutic methylprednisolone is approved for clinical use for a variety of disorders. Medrol®, the agent to be used in this study, is manufactured by Pfizer.
Medrol® is supplied as white tablets, of 4mg each. The tablets come in a commercially produced blister pack with instructions for each day of the 6 day dosing on the packaging. Subjects will receive a standard 6-day, graded dosing regimen of methylprednisolone (24mg, 20mg, 16mg, 12mg, 8mg, and 4 mg on days 1 through 6 respectively, Table 1 above). This methylprednisolone dosing regimen is commonly prescribed for the treatment of inflammation associated with a number of pathologies, including arthritic, respiratory, and neoplastic diseases. The Medrol® pack has clear instructions on how to administer the tablets and participants will be given additional instruction to ensure understanding for proper self-administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: MethylprednisoloneMethylprednisolone glucocorticoid Medrol Dose Pack Medrol is supplied as white tablets, of 4mg each. The tablets come in a commercially produced blister pack with instructions for each day of the 6 day dosing on the packaging. Subjects will receive a standard 6-day, graded dosing regimen of methylprednisolone (24mg, 20mg, 16mg, 12mg, 8mg, and 4 mg on days 1 through 6 respectively). |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages: 60 - 80 years.
- For men only: Eugonadal men, with a basal serum testosterone level for men within the normal range for the assay.
- For women only: women must be post-menopausal.
- Availability of transportation (i.e., subjects must be able to provide their own transportation to TAMU HCRF).
- Ability to fast for 12 hours before each of the study visits
Key exclusion criteria (21 listed)
- Use of anticoagulant due to the risk of bleeding during the muscle biopsy procedure.
- Current use or history of recent use of anabolic steroids or glucocorticoids (within 3 months).
- Use of anti-bone-resorptive agents such as bisphosphonates, parathyroid hormone, or calcitonin.
- Use of live virus vaccines in the past 30 days.
- History of stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneAlso: Medrol Dose Pack, Medrol6 day dosing as dictated by Medrol 6 Day Dose Pack | Drug | Methylprednisolone |
Primary outcome
Oxidative Phosphorylation Capacity measured by high resolution tissue respirometry on day 0
Time frame: day 0
Oxidative Phosphorylation will be measured in muscle tissue using high resolution respirometry (Oroboros O2K) on day 0.
Oxidative Phosphorylation Capacity measured by high resolution tissue respirometry on day 6
Time frame: day 6
Oxidative Phosphorylation will be measured in muscle tissue using high resolution respirometry (Oroboros O2K) on day 6, after the 6 day methylpredinsolone treatment.
Expression level of NFKB Inducing Kinase (NIK) in tissue measured by real time PCR on day 0
Time frame: day 0
NIK expression will be measured in muscle tissue using real time PCR on day 0.
Expression level of NFKB Inducing Kinase (NIK) in tissue measured by real time PCR on day 6
Time frame: day 6
NIK expression will be measured in muscle tissue using real time PCR on day 6, after the 6 day methylprednisolone treatment.
4 secondary outcomes
Lean Body Mass as measured by Dual Energy X-Ray Absorptiometry on day 0
Time frame: day 0
Lean Body Mass as measured by Dual Energy X-Ray Absorptiometry on day 6
Time frame: day 6
Fat Mass as measured by Dual Energy X-Ray Absorptiometry on day 0
Time frame: day 0
Fat Mass as measured by Dual Energy X-Ray Absorptiometry on day 6
Time frame: day 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melinda Sheffield-Moore, PhD principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone in people with Aging, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative Phosphorylation Capacity measured by high resolution tissue respirometry on day 0 (time frame: day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.